Device Recall VITEK 2 GP ID Test card

  • Modèle / numéro de série
    Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom
  • Description du dispositif
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. || VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Société-mère du fabricant (2017)
  • Source
    USFDA